EP1715809B1 - Prolaps-reparatur - Google Patents

Prolaps-reparatur Download PDF

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Publication number
EP1715809B1
EP1715809B1 EP05714066A EP05714066A EP1715809B1 EP 1715809 B1 EP1715809 B1 EP 1715809B1 EP 05714066 A EP05714066 A EP 05714066A EP 05714066 A EP05714066 A EP 05714066A EP 1715809 B1 EP1715809 B1 EP 1715809B1
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EP
European Patent Office
Prior art keywords
surgical instrument
inches
implant
distal end
helical portion
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EP05714066A
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English (en)
French (fr)
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EP1715809A1 (de
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Georges Pavillion K MELLIER
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AMS Research LLC
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AMS Research LLC
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B17/06109—Big needles, either gripped by hand or connectable to a handle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00805—Treatment of female stress urinary incontinence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A61B2017/06009—Means for attaching suture to needle having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/06076—Needles, e.g. needle tip configurations helically or spirally coiled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings

Definitions

  • Surgical approaches vary. They include vaginal, abdominal and laparoscopic surgical approaches. See Richter K: Massive Eversion of the Vagina: Pathogenesis, Diagnosis and Therapy of the True Prolapse of the Vaginal Stump, Clin. Obstet Gynecol 25:897-912 (1982) ; Diana et al., Treatment of Vaginal Vault Prolapse with Abdominal Sacral Colpopexy Using Prolene Mesh, American Journal of Surgery, Vol. 179, (Feb. 2000), Pps.
  • Abdominal sacral colpopexy is considered to be an especially efficacious treatment, but it has been criticized for its inability to address posterior wall defects or perineal descent problems. This can result in persistent or altered defactory issues. See Bassler et al., Abdominal Sacrocolpopexy and Anatomy and Function of the Posterior Compartment, Obstet. Gyn 2001; 97:678-683 . These procedures are generally considered invasive.
  • Sacrospinous ligament suspensions are also popular. However, these procedures have been criticized for distorting support symmetry about the vaginal axis. This could contribute to a predisposition for future defects in the anterior compartment. See Paraiso et al., Pelvic support defects and visceral and sexual function in women treated with sacrospinous ligament suspension and pelvic reconstruction. Am J Obstet Gyn 1996; 175:1423-1431 . See also, Guner et al., Transvaginal Sacrospinous Colpopexy For Marked Uterovaginal and Vault Prolapse, Inter. J. of Gynec. & Obstetrics, 74 (2001) Pps. 165-170 . This fixation is believed to risk complications through damage to the pudendal neurovascular bundle and sciatic nerve. Uterosacral ligament suspension is another repair procedure, but risk of ureteral injury still exists.
  • the device comprises an elongate, flexible, pierced material, a suture connected to the material and a suture needle joined to the suture.
  • the device is long enough to enable posterior suspension of the vagina at the promontory (i.e. the front upper part of the sacrum).
  • the other end of the device includes a distal portion having a width such that it can cover at least a large part of the posterior part of the vagina, a rounded cut-out with dimensions that enable it to be engaged around the base of the vagina on at least a large part of the lower half of the wall of the vagina.
  • the suture is connected to the article so that it is offset sidewise in relation to the cut-out.
  • PCT Publication No. WO 00/27304 discloses a suspension device for treating prolapse and urinary incontinence.
  • the device comprises at least one filiform suspension cord with limited elasticity and at least two anchoring parts linked to the ends of the cord.
  • PCT Publication No. WO 02/078552-A1 discloses an apparatus for treating vaginal vault disorders.
  • U.S. Pat. No. 5,112,344 and PCT Publication WO 0232284 disclose surgical devices for female pelvic health procedures.
  • the IVS Tunneller device is available from U.S. Surgical of Norwalk, CT.
  • the IVS device comprises a fixed delta wing handle, a hollow metal tube and a stylet that is placeable within the tube.
  • the stylet has a rounded plastic tip on one end and an eyelet at the other end.
  • the device may be used to implant a polypropylene tape for infracoccygeal sacropexy and other surgical procedures.
  • a single, rigid, hollow metal tube is associated with the IVS Tunneller device. This single tube passes through two separate regions of the patient's body with the attendant risk of cross contamination.
  • the outer diameter of the tube is also relatively large (about 0.635 cm (0.25 inches)) with the attendant risk of tissue damage due to a large diameter needle.
  • the polypropylene tape supplied with the TVS Tunneller is a thin, rectangular shape, believed to be approximately 8 mm x 350 mm.
  • the thin, rectangular tape supplied with the IVS Tunneller is not believed to be extensible. Under a longitudinal force, the implant is highly resistant to elongation. It is believed that inextensible polypropylene tapes may be apt to exhibit a greater association with erosion and failure.
  • a recent abstract describes using a 15 x 14 cm implant, placed transvaginally, to repair the anterior, median perineal defect. See Mouly et al., Vaginal Reconstruction of a Complete Vaginal Prolapse: The Trans Obturator Repair, Journal of Urology, April 2003, Vol 169 (4) supplement, p 183, Abstract # V 702, AUA April 26 - May 1, 2003, Chicago , Illinois. The abstract also discloses that wings of the mesh are inserted through the obturator holes. Another publication describes an anterior wall repair. See Salomon et al., Treatment of Anterior Vaginal Wall Prolapse with Porcine Skin Collagen Implant by the Transobturator Route: Preliminary Results; European Urology 45 (2004), 219-245 . This procedure utilizes an Emmet needle to pierce the obturator foramen.
  • EP-A-1 342 454 describes a surgical instrument for implanting an implantable material to treat incontinence, the instrument comprising a handle portion, a second portion having substantial structure in three dimensions and a distal region, the second portion including a needle portion having a portion that is sized and shaped to extend between an incision substantially adjacent the patient's obturator foramen and a vaginal incision; and the needle portion having structure in the distal region for associating the instrument with an implantable material for treating the incontinence.
  • EP-A-1 342 454 also describes a surgical instrument comprising a handle and a needle portion having an straight portion emerging from the handle and a generally helical portion having a distal end region, which corresponds to the preamble of the independent claim 1.
  • the present invention is directed to novel surgical instruments for surgical procedures that treat prolapse.
  • the invention is specified by the features of the claim 5.
  • the present invention comprises a surgical instrument for inserting an implant for treating female prolapse.
  • the surgical instrument comprises a handle and a needle portion.
  • the needle portion has a straight portion emerging from the handle and a generally helical portion having a distal end region.
  • the needle portion is sized and shaped so that the distal end region may initially be moved through a patient's obturator foramen toward the region of the patient's ischial spine, and then toward a vaginal incision in the region of the vaginal apex, so that an implant may be received by the distal end of the needle and moved from the vaginal incision through the patient's obturator foramen.
  • the helical portion may comprise either a left or a right handed helical portion.
  • the needle portion has a generally circular cross section with a diameter of less than about 5.5 mm and more than about 0.5 mm.
  • the straight portion of the instrument has a longitudinal axis and the helical portion has a length, measured along the longitudinal axis of the straight portion, of more than 2 inches and less than twelve inches.
  • the helical portion has a width of more than about 2.54 cm (1 inch) and less than about 22.86 cm (9 inches).
  • the helical portion has a pitch of at least 5.08 cm (2 inches) and less than seven inches and a radius of at least 1.27 cm (0.5 inches) and less than 10.16 cm (four inches).
  • the straight portion of the instrument has a longitudinal axis and the helical portion has an axis that is not parallel to the axis of the straight portion.
  • the axis of the straight portion and the axis of the helical portion form an angle, preferably of about 8 degrees.
  • the distal end portion of the instrument points away from the handle and at an acute angle relative to a plane that is perpendicular to the longitudinal axis of the straight portion of the instrument.
  • the present invention comprises an assembly of surgical instruments for treating female prolapse.
  • the assembly comprises a first surgical instrument comprising a handle; a needle portion having a straight portion emerging from the handle and a generally right handed helical portion having a distal end region.
  • the needle portion is sized and shaped so that the distal end region may initially be moved through a patient's obturator foramen toward the region of the patient's ischial spine, and then toward a vaginal incision in the region of the vaginal apex.
  • the assembly includes a second surgical instrument comprising a handle; a needle portion having a straight portion emerging from the handle and a generally left handed helical portion having a distal end region.
  • the needle portion of the second needle is sized and shaped so that the distal end region may initially be moved through a patient's obturator foramen toward the region of the patient's ischial spine, and then toward a vaginal incision in the region of the vaginal apex.
  • the assembly also includes an implant for treating the prolapse.
  • the assembly may include a pair of dilating connectors and insertion sleeves surrounding the implant.
  • the distal end portions of the needles may include eyelets.
  • the implant may be extensible or inextensible.
  • an insertion sleeve accompanies extensible implant.
  • a surgical procedure which does not form part of the invention is also described.
  • the surgical procedure can include the steps of: i) providing a first surgical instrument comprising a handle, a needle portion having a straight portion emerging from the handle and a generally right handed helical portion having a distal end region; a second surgical instrument comprising a handle, a needle portion having a straight portion emerging from the handle and a generally left handed helical portion having a distal end region; ii) creating a vaginal incision; iii) incising the patient's skin in the region of the patient's obturator foramen on a first side of the patient, iv) passing the distal end portion of the first surgical instrument through the obturator foramen and then through the vaginal incision; v) associating the implant with the first surgical instrument; vi) incising the patient's skin in the region of the patient's obturator foramen on a second side of the patient, vii) passing the
  • the step of creating a vaginal incision includes the step of creating a vaginal incision in a region of the apex of the vagina.
  • the step of passing the distal end portion of the first surgical instrument through the obturator foramen and then through the vaginal incision includes the step of passing the distal end of the instrument through the inferior part of the obturator membrane in the region of the obturator foramen above the ischio-pubic ramus.
  • Figures 1- 3A illustrate a surgical instrument for use on one side of the patient's body.
  • Figures 4-6A disclose a surgical instrument for use on the opposite side of the patient's body.
  • the surgical instrument 10 includes a straight portion 12, a helical portion 14, and a distal end region 15.
  • the surgical instrument 20 includes a straight portion 22, a helical portion 24, and a distal end region 25.
  • the surgical instruments 10 and 20 include handles 11 and 21 ( Fig. 8 ) which are not shown in Figures 1-6A .
  • the surgical instruments 10 and 20 are adapted for a surgical procedure for reconstruction of the vaginal vault, as described more fully below.
  • the cross sectional shape of the straight and helical portions can be of a wide variety of shapes and is preferably small.
  • the diameter is preferably less than about 5.5 mm and more than about 0.5 mm.
  • the surgical instrument 10 may have a diameter of 0.3175 cm (0.125 inches).
  • the length L1' is preferably more than about 12.7 cm (5 inches) and may be about 15.24 cm (6 inches), the length L2' is preferably more than 2.54 cm (1 inch), more preferably more than 5.08 cm (2 inches) and even more preferably about 7.01 cm (2.76 inches).
  • the length L1' is preferably less than 30.48 cm (twelve (12) inches).
  • the width W' is preferably more than 2.54 cm (one inch) and less than about 22.86 cm (9 inches). In a preferred embodiment the width W' may be about 5.461 cm (2.15 inches). Preferably about 5.08 cm (two inches) of the straight portion 12 project from the end of the handle 11.
  • the helical portion 14 preferably has a radius of at least 1.27 cm (0.5 inches), more preferably 2.096 cm (0.825 inches) and a pitch of at least about 5.08 cm (2 inches) preferably about 9.271 cm (3.65 inches).
  • the surgical instrument may be formed about a mandrel with a diameter of 3.81 cm (1.5 inches) and a groove (for receiving the surgical instrument) with a pitch of 7.62 cm (3 inches).
  • the axis A' of the helical portion 14 is offset from the longitudinal axis of the straight portion 12 (see Figures 1 and 3 ). In this embodiment, the offset is about 8 degrees. In a preferred embodiment, the offset for both instruments 10 and 20 is the same and at least 5 degrees.
  • the bend between the straight and helical portions 12 and 14 may have a radius of about 0.762 cm (0.3 inches).
  • the distal end portion 15 of the surgical instrument points away from the handle 11 ( Fig. 8 ) and at an acute angle relative to a plane that is perpendicular to the longitudinal axis of the straight portion 12 of the instrument.
  • length L1 may be about 15.24 cm (6 inches)
  • the length L2 is about 7.01 cm (2.76 inches)
  • width W of about 5.461 cm (2.15 inches).
  • the axis A of the helical portion 24 is offset from the longitudinal axis of the straight portion 22.
  • the helical portion 24 preferably has a radius of 2.096 cm (0.825 inches) and a pitch of about 9.271 cm (3.65 inches).
  • the ranges for the size and shape of the instrument 20 are the same as described above for the instrument 10.
  • the surgical instruments 10 and 20 may be constructed from any suitable polymeric or metallic material.
  • One suitable material is stainless steel 17-4 PH hardened to H900.
  • Figure 8 shows an assembly of surgical articles 10, 20 and 30 for treating prolapse.
  • the assembly preferably includes surgical articles 10 and 20 and an implant assembly 30 with dilating connectors 35, implant 34 and separable insertion sheath 32.
  • the dilators and insertions sheath are optional.
  • the distal end portions of the surgical instruments 10 and 20 may include eyelets for receiving the implant 34.
  • the distal end regions 15 and 25 may have surfaces that are specially shaped to engage complementary surfaces on the dilating connectors 35 of an implant assembly 30.
  • Such assemblies are disclosed in published U.S. Pat. Application Nos. 2003/0171644-A1 and 2003/0176875-A1 .
  • the implant assemblies 30 typically include an implantable material 34 that remains in the body.
  • the implantable material may comprise synthetic or non-synthetic materials or hybrids, composites or combinations thereof.
  • a synthetic material is preferable.
  • Suitably synthetic materials include polymerics, and plastics, and any combination of such materials. Commercial examples of such materials include Mersile TM , Teflon TM , Gore-Tex TM , Silastic TM , Marlex TM , Prolene TM , and Vaskutek TM . Other examples of suitable materials include those disclosed in U.S. Patent No. 6,652,450 . Specific examples of synthetic sling materials include absorbable and non-absorbable materials such as polypropylene, polyethylene, nylon, PLLA and PGA. Additional meshes are disclosed in Dietz et al., Mechanical Properties of Urogynecologic Implant Materials, Int. Urogynecol. J. (2003) 14: 239-243 ; and Iglesia et al., The Use of Mesh in Gynecologic Surgery, Int. Urogynecol. J. (1997) 8:105-115 .
  • Possible non-synthetic materials include allografts, homografts, heterografts, autologous tissues, cadaveric fascia and fascia lata.
  • Figure 7 shows a prolapsed vagina V and a female pelvis with obturator foramen O.
  • Figures 9 through 22 illustrate one example of a surgical procedure for treating prolapse.
  • the goal of the procedure is to perform a vaginal vault suspension using an implant fixed relative to the vagina (e.g. on or near the vaginal apex).
  • Fig. 8 shows surgical instruments 10 and 20 and implant assembly 30 that are conveniently assembled for purposes of conducting the subsequent surgery.
  • the surgical instruments 10 and 20 and implant assembly 30 may optionally be packaged together and opened just prior to the procedure.
  • the implant assembly 30 preferably includes an implantable surgical mesh 34, a separable insertion sleeve 32 and a pair of dilating connectors 35.
  • the implant 34 For fitting the implant 34, at least two routes are possible: one with an anterior dissection and one with posterior dissection. This procedure can be conducted after previous or concomitant hysterectomy and in cases of uterus preservation.
  • specific instruments 10 and 20 are passed through the membrane OM in the region of the obturator foramen O to place the implant 34.
  • the implant 34 stabilizes the vaginal vault by fixation on both sides through, e.g, pelvic muscles and membranes.
  • the posterior vaginal wall is incised longitudinally from the apex AP down to the perineum incision. (Lowest part incision may be done for posterior myorraphy).
  • the rectum is dissected from the vaginal wall, preferably substantially the entire portion.
  • the para-rectal space is opened in both sides with dissection deeply to the ischial spines IS.
  • the index finger of the surgeon can palpate levator ani and deeper, the ischial spine IS.
  • FIG 9 schematically illustrates a preferred needle passage.
  • the needle passage is preferably through the inferior part of the obturator membrane O in the region of the obturator foramen above the ischio-pubic ramus.
  • the distal end portion 15 of the instrument 10 is pushed through the obturator membrane O.
  • the distal end portion 15 is moved initially toward the region of the patient's ischial spine IS.
  • the surgeon's index finger can palpate the needle tip through the muscular wall going to the ischial spine IS.
  • the distal end 15 of the instrument is pushing out through the levator ani when it arrives at the level of the spine.
  • Fig. 11 shows the surgeon's finger palpating the distal end 15 of the needle.
  • Figure 12 shows the arrangement after the distal end portion of the needle after it has passed through a vaginal incision I.
  • Fig. 13 the surgeon moves the dilating connector 35 of the implant assembly 30 toward the end portion 15 of the needle.
  • the dilating connector 35 is then connected to the needle tip ( Fig. 14 ). This is shown taking place within the vaginal region. Preparation for this step is shown in Fig. 13 .
  • the needle 12 is pulled back out obturator O and the implant assembly 30 is essentially in place on one side of the patient.
  • Fig. 17 illustrates a scissors S after it has separated the surgical instrument 10 and dilating connector 35 from the remaining portion of the implant assembly 30.
  • the implant 34 may be fixed to the vaginal wall with two stitches 101 about 1.5cm from the apex AP. It can also be fixed to the rectum (e.g. in the region or directly to) with two other stitches.
  • the implant 34 is between the vagina and rectum. Its passage through the levator ani is on both sides, the fixation point of the vaginal vault suspension.
  • Fig. 21 shows the corrected prolapse with the vagina V supported by implant 34.
  • the posterior repair can be accomplished with posterior perineo-myorraphy and some times plications of the rectal fascia.
  • the vaginal wall may be closed with a suture from the vaginal apex to the lowest region of the perineum.
  • the stabilization of the vaginal vault can also be accomplished with an anterior route (e.g. if the surgeon prefers this route for surgical reasons).
  • the implant 34 may be implanted by anterior dissection of the anterior vaginal wall.
  • the bladder is dissected off the vagina.
  • the para-vesical space is opened on both sides going to the ischial spines IS.
  • the needles 10 and 20 may be used similarly in the posterior procedure and the implant can be fit through muscular wall in both sides.
  • the implant 34 may be fixed to the anterior part of the vaginal vault at the apex AP.

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  • Life Sciences & Earth Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Claims (13)

  1. Chirurgisches Instrument (10, 20), das aufweist:
    einen Griff (11, 21);
    einen Nadelteil mit einem geradlinigen Abschnitt (12, 22), der vom Griff (11, 21) austritt, und einen im Allgemeinen spiralförmigen Abschnitt (14, 24), der einen distalen Endbereich (15, 25) aufweist, wobei der spiralförmige Abschnitt (14, 24) eine Breite von mehr als etwa 3,81 cm (1,5 Zoll) und weniger als etwa 21,59 cm (8,5 Zoll) sowie einen Radius von mindestens etwa 1,27 cm (0,5 Zoll) aufweist,
    wobei der Nadelteil so dimensioniert und geformt ist, dass der distale Endbereich (15, 25) zuerst durch das Foramen obturatorium einer Patientin bewegt und in Richtung des Sitzbeinbereichs der Patientin und anschließend in Richtung einer vaginalen Inzision im Bereich des vaginalen Apex geschoben werden kann, so dass am distalen Ende (15, 25) der Nadel ein Implantat aufgenommen und durch die vaginale Inzision hindurch durch das Foramen obturatorium der Patientin bewegt werden kann;
    dadurch gekennzeichnet, dass die Neigung des spiralförmigen Abschnitts des Griffes mindestens 5,08 cm (2 Zoll) lang ist und dass der geradlinige Abschnitt (12, 22) des Instruments (10, 20) eine Längsachse hat und der spiralförmige Abschnitt (14, 24) eine Achse (A, A') hat, die nicht parallel zur Achse des geradlinigen Abschnitts ist.
  2. Chirurgisches Instrument nach Anspruch 1, wobei der im Allgemeinen spiralförmige Abschnitt (14, 24) einen linkshändig anwendbaren spiralförmigen Abschnitt aufweist.
  3. Chirurgisches Instrument nach Anspruch 1, wobei der im Allgemeinen spiralförmige Abschnitt (14, 24) einen rechtshändig anwendbaren spiralförmigen Abschnitt aufweist.
  4. Chirurgisches Instrument nach Anspruch 1, wobei der Nadelteil einen im Allgemeinen kreisförmigen Querschnitt mit einem Durchmesser von weniger als etwa 5,5 mm und mehr als etwa 0,5 mm aufweist.
  5. Chirurgisches Instrument nach Anspruch 1, wobei die Länge des spiralförmigen Abschnitts (14, 24) bei Messung entlang der Längsachse des geradlinigen Abschnitts mehr als 5,08 cm (2 Zoll) und weniger als 30,48 cm (12 Zoll) beträgt.
  6. Chirurgisches Instrument nach Anspruch 1, wobei der spiralförmige Abschnitt (14, 24) eine Breite von etwa 5,461 cm (2,15 Zoll) aufweist.
  7. Chirurgisches Instrument nach Anspruch 6, wobei der spiralförmige Abschnitt (14, 24) eine Neigung von etwa 7,62 bis etwa 9,271 cm (3 bis etwa 3,65 Zoll) und einen Radius von etwa 2,0955 cm (0,825 Zoll) aufweist.
  8. Chirurgisches Instrument nach Anspruch 1, wobei die Achse des geradlinigen Abschnitts und die Achse des spiralförmigen Abschnitts (A, A') einen Winkel von etwa 8 Grad bilden.
  9. Chirurgisches Instrument nach Anspruch 1, wobei der distale Endabschnitt des Instruments vom Griff (11, 21) weg weist und in einem spitzen Winkel relativ zu einer Ebene senkrecht zur Längsachse der geradlinigen Abschnitts (12, 22) des Instruments (10, 20) verläuft.
  10. Chirurgisches Instrument nach Anspruch 1, das für das Einfügen eines Implantats (34) zur Behandlung eines weiblichen Prolapses angepasst ist.
  11. Ausrüstungssatz (30) von chirurgischen Instrumenten für die Behandlung eines weiblichen Prolapses, wobei der Ausrüstungssatz aufweist:
    ein erstes chirurgisches Instrument (10, 20) nach Anspruch 3;
    ein zweites chirurgisches Instrument (10, 20) nach Anspruch 2;
    und ein Implantat (34) zur Behandlung des Prolapses.
  12. Ausrüstungssatz (30) von chirurgischen Instrumenten nach Anspruch 11, die ferner ein Paar Dilatationsverbinder (35) und Einführhüllen (32), die das Implantat (34) umgeben, aufweisen.
  13. Ausrüstungssatz (30) nach Anspruch 11, angepasst für die Behandlung eines weiblichen Prolapses.
EP05714066A 2004-02-19 2005-02-22 Prolaps-reparatur Expired - Lifetime EP1715809B1 (de)

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US54598704P 2004-02-19 2004-02-19
PCT/US2005/006039 WO2005079702A1 (en) 2004-02-19 2005-02-22 Prolapse repair

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EP1715809A1 EP1715809A1 (de) 2006-11-02
EP1715809B1 true EP1715809B1 (de) 2008-05-07

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AT (1) ATE394077T1 (de)
AU (1) AU2005215814B2 (de)
CA (1) CA2556193C (de)
DE (1) DE602005006528D1 (de)
WO (1) WO2005079702A1 (de)

Families Citing this family (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007002071A1 (en) 2005-06-21 2007-01-04 Ams Research Corporation Apparatus for securing a urethral sling to pubic bone
WO2007002012A1 (en) 2005-06-21 2007-01-04 Ams Research Corporation Apparatus for securing a urethral sling to pubic bone
CA2615130A1 (en) 2005-07-26 2007-02-08 Ams Research Corporation Methods and systems for treatment of prolapse
CN101420909B (zh) 2006-02-16 2011-08-03 Ams研究公司 用于治疗盆腔疾病的手术装置和方法
WO2007137226A2 (en) 2006-05-19 2007-11-29 Ams Research Corporation Method and articles for treatment of stress urinary incontinence
BRPI0712194A2 (pt) 2006-06-16 2012-03-06 Ams Research Corporation Implantes pélvico e cirúrgico combinação ferramenta cirúrgica útil para implantar um implante pélvico métodos de tratamento de uma condição pélvica, e de prolapso vaginal, e, método para manipular um implante cirúrgico
WO2007149593A2 (en) 2006-06-22 2007-12-27 Ams Research Corporation Adjustable tension incontinence sling assemblies
WO2008057261A2 (en) 2006-10-26 2008-05-15 Ams Research Corporation Surgical articles for treating pelvic conditions
US8951185B2 (en) 2007-10-26 2015-02-10 Ams Research Corporation Surgical articles and methods for treating pelvic conditions
BRPI0817018A2 (pt) 2007-09-21 2015-03-24 Ams Res Corp Ferramenta para inserção cirúrgica, combinação de ferramenta com uma extensão de um implante, e, método para implantar um implante em um paciente
US8727963B2 (en) 2008-07-31 2014-05-20 Ams Research Corporation Methods and implants for treating urinary incontinence
US9017243B2 (en) 2008-08-25 2015-04-28 Ams Research Corporation Minimally invasive implant and method
WO2010027796A1 (en) 2008-08-25 2010-03-11 Ams Research Corporation Minimally invasive implant and method
KR101719512B1 (ko) 2008-10-27 2017-04-04 에이엠에스 리서치 코포레이션 신축자재한 요소를 갖는 앵커 시스템 및 외과 수술용 바늘
CA2748894C (en) 2009-02-10 2018-11-13 Ams Research Corporation Surgical articles and methods for treating urinary incontinence
WO2011082287A1 (en) 2009-12-30 2011-07-07 Ams Research Corporation Implant systems with tensioning feedback
AU2010339416B2 (en) 2009-12-30 2013-10-17 Boston Scientific Scimed, Inc. Implantable sling systems and methods
AU2010339575B2 (en) 2009-12-30 2013-04-18 Boston Scientific Scimed, Inc. Elongate implant system and method for treating pelvic conditions
US9393091B2 (en) 2009-12-31 2016-07-19 Astora Women's Health, Llc Suture-less tissue fixation for implantable device
US9445881B2 (en) 2010-02-23 2016-09-20 Boston Scientific Scimed, Inc. Surgical articles and methods
EP3721832B1 (de) 2010-02-23 2023-03-29 Boston Scientific Scimed, Inc. Chirurgische artikel für inkontinenzbehandlung
DE102010013917A1 (de) * 2010-04-01 2011-10-06 Karl Storz Gmbh & Co. Kg Medizinisches Instrument für einen minimalinvasiven Eingriff
US10028813B2 (en) 2010-07-22 2018-07-24 Boston Scientific Scimed, Inc. Coated pelvic implant device and method
US9572648B2 (en) 2010-12-21 2017-02-21 Justin M. Crank Implantable slings and anchor systems
US9125717B2 (en) 2011-02-23 2015-09-08 Ams Research Corporation Implant tension adjustment system and method
US8808162B2 (en) 2011-03-28 2014-08-19 Ams Research Corporation Implants, tools, and methods for treatment of pelvic conditions
US20120253108A1 (en) 2011-03-28 2012-10-04 Fischer Brian G Implants, tools, and methods for treatment of pelvic conditions
US9492259B2 (en) 2011-03-30 2016-11-15 Astora Women's Health, Llc Expandable implant system
US10058240B2 (en) 2011-06-29 2018-08-28 Boston Scientific Scimed, Inc. Systems, implants, tools, and methods for treatments of pelvic conditions
US20130006049A1 (en) 2011-06-30 2013-01-03 Alexander James A Implants, tools, and methods for treatments of pelvic conditions
US9351723B2 (en) 2011-06-30 2016-05-31 Astora Women's Health, Llc Implants, tools, and methods for treatments of pelvic conditions
EP2734148B1 (de) 2011-07-22 2019-06-05 Boston Scientific Scimed, Inc. Beckenimplantatsystem
US9414903B2 (en) 2011-07-22 2016-08-16 Astora Women's Health, Llc Pelvic implant system and method
US9492191B2 (en) 2011-08-04 2016-11-15 Astora Women's Health, Llc Tools and methods for treatment of pelvic conditions
US20130035555A1 (en) 2011-08-05 2013-02-07 Alexander James A Systems, implants, tools, and methods for treatment of pelvic conditions
US10098721B2 (en) 2011-09-01 2018-10-16 Boston Scientific Scimed, Inc. Pelvic implant needle system and method
USD721175S1 (en) 2011-09-08 2015-01-13 Ams Research Corporation Backers for surgical indicators
USD736382S1 (en) 2011-09-08 2015-08-11 Ams Research Corporation Surgical indicator with backers
USD721807S1 (en) 2011-09-08 2015-01-27 Ams Research Corporation Surgical indicators
US10265152B2 (en) 2011-10-13 2019-04-23 Boston Scientific Scimed, Inc. Pelvic implant sizing systems and methods
US9192458B2 (en) 2012-02-09 2015-11-24 Ams Research Corporation Implants, tools, and methods for treatments of pelvic conditions

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0437481B1 (de) 1988-10-04 1995-03-15 PETROS Peter Emmanuel Chirurgisches instrument, prothese
FR2785521B1 (fr) 1998-11-10 2001-01-05 Sofradim Production Dispositif de suspension pour le traitement de prolapsus et d'incontinences urinaires
FR2792824B1 (fr) 1999-04-27 2001-06-22 Sofradim Production Dispositif de traitement de prolapsus par suspension vaginale
US6802807B2 (en) 2001-01-23 2004-10-12 American Medical Systems, Inc. Surgical instrument and method
AUPR406501A0 (en) 2001-03-28 2001-04-26 Kaladelfos, George Treatment of vault prolapse
WO2003075792A1 (en) * 2002-03-07 2003-09-18 Ams Research Corporation Transobturator surgical articles and methods
EP1542596B1 (de) * 2002-08-29 2010-11-24 Université de Liège Vorrichtungen für die chirurgische behandlung der harninkontinenz bei frauen

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CA2556193A1 (en) 2005-09-01
DE602005006528D1 (de) 2008-06-19
WO2005079702A1 (en) 2005-09-01
EP1715809A1 (de) 2006-11-02
ATE394077T1 (de) 2008-05-15
AU2005215814A1 (en) 2005-09-01
CA2556193C (en) 2012-12-04
AU2005215814B2 (en) 2010-06-24

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